Executive Summary:
This notification announces amendments to the Drugs and Cosmetics Rules, 1945, following consideration of public feedback. The amendments, called the Drugs and Cosmetics Eleventh Amendment Rules, 2019, address the duration of licenses and loan licenses, and other modifications to forms and rules. These rules come into force on the date of publication in the Official Gazette, July 17, 2019.
Key Points / Main Content:
License Duration and Retention:
* A license issued in Form 28, Form 28B, and Form 28D remains valid if the licensee deposits a license retention fee every five years from the date of issue.
* The license retention fee equals the original license fee (excluding the initial inspection fee).
* Failure to pay the retention fee on time results in a late fee of 2% per month (up to six months); non-payment leads to license cancellation.
* Loan licenses issued in Form 28A and Form 28DA are subject to the same retention fee and late fee rules as above.
Rule and Form Modifications:
* In rule 140(1), "Form 33" is removed, leaving "Form 32 and Form 32A."
* In rule 143A(1), "or Form 33" is omitted.
* In rule 150E(e), "or renewal" is omitted.
* Rule 150J is omitted entirely.
* In Schedule A, Form 24C, the words "OR RENEWAL" are added in the heading and paragraph 1.
* Form 26J, related to the renewal of loan licenses for specific substances, is omitted.
* In Form 37, the reference to "any certificate of renewal in Form 38" is omitted.
Impact Analysis:
Licensees (Forms 28, 28B, 28D, 28A, 28DA):
* Impact: Licensees must now pay a retention fee every five years to maintain the validity of their licenses. Failure to do so results in late fees and potential license cancellation.
* Action Required: Licensees must budget for and pay the retention fee on time to avoid penalties and ensure their licenses remain valid.
Licensing Authority:
* Impact: The licensing authority is responsible for processing retention fee payments and managing licenses that may be suspended or cancelled due to non-payment.
* Action Required: The licensing authority needs to implement procedures for managing the new retention fee process and handling potential license cancellations.
Manufacturers (Large Volume Parenterals, Sera, Vaccines, Recombinant DNA Drugs):
* Impact: The removal of Form 26J eliminates the renewal process for loan licenses related to these products.
* Action Required: Manufacturers need to be aware of the change and adjust their procedures accordingly, focusing on initial license applications rather than renewals using Form 26J.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament governing drugs and cosmetics. This notification references sections of this act.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare policies, under which the Department of Health and Family Welfare operates.
Department of Health and Family Welfare: The department within the Ministry of Health and Family Welfare that issued the notification.
Drugs Technical Advisory Board: A board consulted by the Central Government in amending the Drugs and Cosmetics Rules.
New Delhi: The location where the notification was issued. New Delhi is the capital of India.
The Gazette of India: The official government gazette in which the notification and principal rules were published.
Drugs and Cosmetics Eleventh Amendment Rules, 2019: The name given to the amendments introduced through this notification to the Drugs and Cosmetics Rules, 1945.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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PUBLISHED BY AUTHORITY
la- 408] ubZ fnYyh] cqèkokj] tqykbZ 17] 2019@vk"kk<+ 26] 1941
No. 408] NEW DELHI, WEDNESDAY, JULY 17, 2019/ASHADHA 26, 1941
(cid:1)(cid:1)(cid:1)(cid:1)वव वव ाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:5)(cid:5) (cid:5)(cid:5) यय यय औऔऔऔरररर पपपप(cid:10)(cid:10)(cid:10)(cid:10)ररररववववाााारररर कककक(cid:12)(cid:12)(cid:12)(cid:12)यय यय ााााणणणण मममम(cid:16)(cid:16)ंं(cid:16)(cid:16)ंं ााााललललयययय
(((((cid:2)(cid:2)(cid:2)(cid:2)वव वव ाााा(cid:2)(cid:2)(cid:2)(cid:2)(cid:6)(cid:6) (cid:6)(cid:6) यययय औऔऔऔरररर पपपप(cid:11)(cid:11)(cid:11)(cid:11)ररररववववाााारररर कककक(cid:13)(cid:13)(cid:13)(cid:13)यय यय ााााणणणण ििििववववभभभभाााागगगग))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:4)द(cid:6)ली, 17 जुलाई, 2019
ससससाााा....ककककाााा....ििििनननन.... 444499999999((((अअअअ))))....————ओषिध और (cid:15)साधन साम(cid:19)ी िनयम, 1945 का और संशोधन करने के िलए कितपय िनयम(cid:29) का
(cid:15)ा(cid:30)प, ओषिध और (cid:15)साधन साम(cid:19)ी अिधिनयम, 1940 (1940 का 23) क धारा 12 क उपधारा (1) और धारा 33 क
उपधारा (1) के अधीन यथापिे #त भारत सरकार के % वा% ’ य और प(रवार क(cid:6) याण मं*ालय (% वा% ’ य और प(रवार क(cid:6)य ाण
िवभाग) क अिधसूचना स.ं सा.का.िन. 608(अ), तारीख 3 जुलाई, 2018 को भारत के राजप*, असाधारण, भाग II, खंड 3,
उप-खंड (i) म . (cid:15)कािशत (cid:4)कया गया था, और उन सभी 0 यि1य(cid:29) स,े िजनके उसस े (cid:15)भािवत होन े क सभं ावना ह,ै उस तारीख से,
िजसको उ4त अिधसचू ना को अ5त6व7 करने वाली राजप* क (cid:15)ितया ं जनता को उपल8ध करा दी गई थी, तीस (cid:4)दन क अविध
के अवसान के पूव9 आ#ेप और सुझाव आमं ि*त (cid:4)कए गए थे;
और, राजप* क (cid:15)ितयां जनता को 6 जुलाई, 2018 को उपल8ध करा दी गई थी;
और, उ4त िनयम(cid:29) पर जनता स े(cid:15)ा=त आ#ेप(cid:29) और सुझाव(cid:29) पर के5 >ीय सरकार ?ारा िवचार कर िलया गया ह;ै
अत: अब, के5> ीय सरकार, ओषिध और (cid:15)साधन साम(cid:19)ी अिधिनयम, 1940 (1940 का 23) क धारा 12 और
धारा 33 के अधीन (cid:15)दHत शि1य(cid:29) का (cid:15)योग करत े Iए, ओषिध तकनीक सलाहकार बोड 9 स े परामश 9 करने के पL चात् ओषिध
और (cid:15)साधन साम(cid:19)ी िनयम, 1945 का और संशोधन करने के िलए िनM निलिखत िनयम बनाती ह,ै अथात9 :्-
1. (1) इन िनयम(cid:29) का सिं #P नाम ओषिध और (cid:15)साधन साम(cid:19)ी (Qयारहवा ँसंशोधन) िनयम, 2019 ह।ै
(2) य ेराजप* म. उनके (cid:15)काशन क तारीख स े(cid:15)वृत ह(cid:29)ग।े
2. ओषिध और (cid:15)साधन साम(cid:19)ी िनयम, 1945 म . (िजस े इसम. इसके पL चात ् उ1 िनयम कहा गया ह)ै के िनयम 76 के
पUात् िनVिलिखत िनयम अ5तः%थािपत (cid:4)कया जाएगा, अथा9त:्-
3658 GI/2019 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
""""77777777.... अअअअनननन(cid:21)(cid:21)ुु(cid:21)(cid:21)ुु िििि(cid:23)(cid:23)(cid:23)(cid:23) कककक(cid:24)(cid:24)(cid:24)(cid:24) अअअअववववििििधधधध ---- (1) (cid:15)(cid:30)प 28, (cid:15)(cid:30)प 28ख और (cid:15)(cid:30)प 28घ म. जारी अनुZिP िविधमा5य रहगे ा य(cid:4)द
अनुZिPधारक इसके जारी होन े क तारीख स े (cid:15)Hयेक उ[रवत\ पांच वष] क अविध समाP होने स े पहल े
उप-िनयम (2) म. िन^द7 अनुZिP (cid:15)ितधारण फ स जमा करता ह,ै जब तक (cid:4)क, यह अनुZिP (cid:15)ािधकारी ?ारा िनलिं बत
या र‘ नहa (cid:4)कया जाता ह।ै
(2) उप-िनयम (1) म . िन^द7 अनुZिP (cid:15)ितधारण फ स अनुZिP (cid:15)दान करन े के िलए भुगतान क गई िन(र#ण फ स
को छोड़कर ऐसी अनुZिP के अनुदान के िलए अपिे #त संबe फ स के समतु(cid:6)य होगा।
(3) य(cid:4)द अनुZिPधारक उप-िनयम (1) म. िन^द7 दये तारीख को या उससे पहले अनुZिP (cid:15)ितधारण फ स का भुगतान
करने म. िवफल रहता ह,ै तो वह (cid:15)Hयके माह के िलए अनZु िP फ स या उसके छह महीन े तक के भाग के िलए, दो
(cid:15)ितशत क दर स े गणना क गई िवलंब फ स के साथ अनुZिP (cid:15)ितधारण शु(cid:6)क का भगु तान करन े के िलए उ[रदायी
होगा और इस तरह क फ स के भुगतान नहa (cid:4)कए जाने के मामले म .अनुZिP र‘ कर दी जाएगी।"
3. उ1 िनयम(cid:29) म,. िनयम 82 के पUात् िनVिलिखत नए िनयम अतं ः%थािपत (cid:4)कया जाएगा, अथात9 ्:-
""""88883333.... ऋऋऋऋणणणण अअअअनननन(cid:21)(cid:21)ुु(cid:21)(cid:21)ुु िििि(cid:23)(cid:23)(cid:23)(cid:23) कककक(cid:24)(cid:24)(cid:24)(cid:24) अअअअववववििििधधधध ---- (1) (cid:15)(cid:30)प 28क और (cid:15)(cid:30)प 28घक म . जारी अनZु िP िविधमा5य रहगे ा य(cid:4)द
अनुZिPधारक इसके जारी होन े क तारीख स े (cid:15)Hयेक उ[रवत\ पांच वष] क अविध समाP होन े से पहल े
उप-िनयम (2) म . िन^द7 अनZु िP (cid:15)ितधारण फ स जमा करता ह,ै जब तक (cid:4)क, यह अनुZिP (cid:15)ािधकारी ?ारा
िनलंिबत या र‘ नहa (cid:4)कया जाता ह।ै
(2) उप-िनयम (1) म . िन^द7 अनुZिP (cid:15)ितधारण फ स अनुZिP (cid:15)दान करने के िलए भुगतान क गई िन(र#ण फ स
को छोड़कर ऐसी अनुZिP के अनुदान के िलए अपिे #त संबe फ स के समतु(cid:6)य होगा।
(3) य(cid:4)द अनुZिPधारक उप-िनयम (1) म. िन^द7 दये तारीख को या उससे पहल ेअनZु िP (cid:15)ितधारण फ स का भगु तान
करन े म . िवफल रहता ह,ै तो वह (cid:15)Hयेक माह के िलए अनुZिP फ स या उसके छह महीने तक के भाग के िलए, दो
(cid:15)ितशत क दर स े गणना क गई िवलंब फ स के साथ अनZु िP (cid:15)ितधारण शु(cid:6)क का भगु तान करने के िलए उ[रदायी
होगा और इस तरह क फ स के भुगतान नहa (cid:4)कए जाने के मामले म .अनुZिP र‘ कर दी जाएगी।"
4. उ1 िनयम(cid:29) के िनयम 140 के उप-िनयम (1) म. ‘(cid:15)(cid:30)प 32, (cid:15)(cid:30)प 32क और (cid:15)(cid:30)प 33’ श8द(cid:29), अकं (cid:29) और अ#र(cid:29) के %थान
पर ‘(cid:15)(cid:30)प 32 और (cid:15)(cid:30)प 32क’ श8द, अंक और अ#र रखे जाएगं े।
5. उ1 िनयम(cid:29) के िनयम 143क के उप-िनयम (1) म .‘या (cid:15)(cid:30)प 33’ श8द(cid:29) और अंक(cid:29) का लोप (cid:4)कया जाएगा।
6. उ1 िनयम(cid:29) के िनयम 150ड़ के खंड (ड़) म .‘या नवीकरण’ श8द(cid:29) का लोप (cid:4)कया जाएगा।
7. उ1 िनयम(cid:29) के िनयम 150ञ का लोप (cid:4)कया जाएगा।
8. उ4त िनयम(cid:29) म,. अनसु ूची क म., –
(क) (cid:15)(cid:30)प 24ग म,.–
(i) शीषक9 म., ‘अनुदान’ श8द के पUात् “या नवीकरण” श8 द अंतः%थािपत (cid:4)कए जाएंग;े
(ii) पैरा 1 म,. “अनुदान” श8द के %थान पर “अनुदान या नवीकरण” श8 द रख ेजाएंगे;
(ख) ‘अनुसूची भ म. िविन^दgट को छोड़कर, अनसु ूची ग और ग-1 म .िविन^दg ट वृहद ्आयतन आं*ते र या सीरा और (टके
या पनु : संयोजक डीएनए (आर-डीएनए) स े iुHपj ओषिधय(cid:29) के िवkय हते ु िविनमा9ण के िलए ऋण अनZु िP का
नवीकरण (cid:15)माणप*’ से संबंिधत (cid:15)(cid:30)प 26ञ का लोप (cid:4)कया जाएगा।
(ग) (cid:15)(cid:30)प 37 म,. उप-शीषक9 “अनमु ोदन क शत”p के परै ा 1 म . “और (cid:15)(cid:30)प 38 म .नवीकरण का कोई (cid:15)माणप*” श8द (cid:29)
और अकं (cid:29) का लोप (cid:4)कया जाएगा।
[फा. सं. ए4स .11014/9/2018-डीआर]
डॉ. मनदीप के. भt डारी, संयु4त सिचव
(cid:10)(cid:10)(cid:10)(cid:10)टटटट(cid:28)(cid:28)(cid:28)(cid:28)पप पप णणणण:::: मलू िनयम भारत के राजप* म. अिधसूचना सuं यांक एफ.28-10/45-एच(1), तारीख 21 (cid:4)दसंबर, 1945 ?ारा (cid:15)कािशत
(cid:4)कए गए थे और अिधसूचना सuं याकं सा.का.िन. 317(अ), तारीख 18 अ(cid:15)ैल, 2019 ?ारा उनका अिं तम सशं ोधन (cid:4)कया
गया।¹Hkkx IIµ[k.M 3(i)] Hkkjr dk jkti=k % vlk/kj.k 3
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 17th July, 2019
G.S.R. 499(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945
was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and
Family Welfare (Department of Health and Family Welfare) number G.S.R. 608(E), dated the 3rd July, 2018, in
the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from
persons likely to be affected thereby before the expiry of a period of thirty days from the date on which the
copies of the Official Gazette containing the said notification were made available to the public;
And whereas copies of Official Gazette were made available to the public on the 6th July, 2018;
And whereas, objections and suggestions received from the public on the said rules have been
considered by the Central Government;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics
Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board,
hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:-
1. (1) These rules may be called the Drugs and Cosmetics (Eleventh Amendment) Rules, 2019.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945 (herein after referred to as the said rules), after rule 76A, the
following rule shall be inserted, namely:-
“77.Duration of licence.- (1) A licence issued in Form 28, Form 28B and Form 28D shall remain
valid, if the licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of
period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by
the licensing authority.
(2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee required
for the grant of such licence excluding inspection fee paid for grant of licence.
(3) If the licencee fails to pay licence retention fee on or before the due date as referred to in
sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of
two per cent. of the licence fee for every month or part thereof up to six months, and in the event of
non-payment of such fee, the licence shall be deemed to have been cancelled.”.
3. In the said rules, after rule 82, the following rule shall be inserted, namely:-
“83.Duration of loan licence.- (1) A loan licence issued in Form 28A and Form 28DA shall remain
valid, if the licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of
period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by
the licensing authority.
(2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee required
for the grant of such licence excluding inspection fee paid for grant of licence.
(3) If the licencee fails to pay licence retention fee on or before the due date as referred to in
sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of
two per cent. of the licence fee for every month or part thereof up to six months, and in the event of
non-payment of such fee, the licence shall be deemed to have been cancelled.”.
4. In the said rules, in rule 140, in sub-rule (1), for the words, figures and letters “Form 32, Form 32A and
Form 33”, the words, figures and letters “Form 32 and Form 32A” shall be substituted.
5. In the said rules, in rule 143A, in sub-rule (1), the words and figures “or Form 33” shall be omitted.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
6. In the said rules, in rule 150E, in clause (e), the words “or renewal” shall be omitted.
7. In the said rules, rule 150J shall be omitted.
8. In the said rules, in Schedule A,―
(a) In Form 24C,―
(i) in the heading, after the words “GRANT”, the words “OR RENEWAL” shall be
inserted;
(ii) in paragraph 1, for the words “grant”, the words “grant or renewal” shall be substituted;
(b) Form 26J relating to “CERTIFICATE OF RENEWAL OF LOAN LICENCE TO
MANUFACTURE FOR SALE OF LARGE VOLUME PARENTERALS OR SERA AND
VACCINE OR RECOMBINANT DNA (R-DNA) DERIVED DRUGS SPECIFIED IN
SCHEDULE C AND C-1 EXCLUDING THOSE SPECIFIED IN SCHEDULE X” shall be
omitted.
(c) in Form 37, under the sub-heading “Conditions of Approval”, in paragraph 1, the words and
figures “and any certificate of renewal in Form 38” shall be omitted.
[F. No. X.11014/9/2018-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note : The principal rules were published in the Gazette of India vide notification number F.28-10/45-H (1),
dated the 21st December, 1945 and last amended vide notification number G.S.R. 317(E), dated the
18th April, 2019.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.